ETHICON Linx Esophagus Sizing Tool

Basic Information

• Brand Name: ETHICON Linx Esophagus Sizing Tool
• Primary DI: 10855106005438
• Version / Model: LST
• Catalog Number: LST
• Company Name: Torax Medical, Inc.
• Labeler DUNS: 137949538
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-23
• Public Version: 1
• Public Version Date: 2020-12-31
• Public Version Status: New
• Public Device Record Key: 408ba3f4-d3da-41a1-9f63-78a75d0d6aff

Device Description

ETHICON Linx Esophagus Sizing Tool

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QJN	Laparoscopic accessories, esophageal sizing	Gastroenterology, Urology	876.5360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35695	Gastro-oesophageal antireflux prosthesis	An implantable device introduced into the gastro-oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. It typically consists of a toroidal, C-shaped elastomer ring filled with a silicone gel that includes a polyester tie to secure the ring around the gastro-oesophageal junction; it is intended for surgical implantation under the diaphragm to hold the lower oesophagus in place as an alternative to traditional surgical fixation of the stomach (i.e., gastropexy) or fundoplication. This GMDN code may reflect old technology.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30855106005432	GS1	CASE	5	In Commercial Distribution
Primary	10855106005438	GS1
Package	20855106005435	GS1	BOX	5	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201035	000